NCT01968096

Brief Summary

Following injury to the spinal cord, the spinal circuit undergoes a series of adaptations. In parallel with the spinal circuit adaptation, the muscular properties also adapt. In human and animal studies, histochemical and physiological evidences showed that the paralyzed muscle transferred from slow, fatigue-resistant to fast, fatigable after injury. Reversal of neuromuscular property for persons with SCI needs to be resolved. Studies using high load electrical stimulations showed a reverse change of muscular properties, such as hypertrophy and reversal of fiber type transformations but failed to show a reversal of spinal circuitry function. Previous studies found that fast continuous passive motion (CPM) altered the H reflex excitability in human. Animal studies found that passive cycling and passive stretching delayed atrophy and influenced the transition of type I and IIa MHC. Theses findings lead to a hypothesis that mechanical stimulation might be able to reverse both spinal circuitry and muscular properties after SCI but it has not been confirmed in human study. The purpose of this project is to investigate the effect of mechanical stimulation by fast CPM on the reversing adaptation of human paralyzed muscle after SCI.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 23, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Last Updated

October 23, 2013

Status Verified

October 1, 2013

Enrollment Period

1.9 years

First QC Date

October 16, 2013

Last Update Submit

October 18, 2013

Conditions

Spinal Cord Injury(SCI)

Keywords

ReflexPost activationSpinal cord injuryPre-synaptic inhibitionMachine driven passive strech

Outcome Measures

Primary Outcomes (1)

  • Clinical muscle tone tests & Peripheral nerve Stimulation machine

    Clinical muscle tone test include Modified Ashworth Scale, Pendulum test ,and withdraw reflex,etc.. Normalization of muscle tone, and influence of muscle property will be evaluated. Peripheral nerve Stimulation machine stimulate Soleus and Tibialis anterior. Restoration of post activation will be evaluated.

    Participants will be followed for the duration of invention, an expected average of 24 weeks.

Study Arms (6)

SCI subjects

NO INTERVENTION

Stage 1 subjects: pilot study:understand post activation depression with spinal cord injury to avoid the influence of the suprasegmental level.

Incomplete SCI subjects

NO INTERVENTION

Stage 2 subjects: pilot study:The strength of depression will be evaluated in individuals with and without SCI.

Health subjects

NO INTERVENTION

Stage 2 subjects: pilot study:The strength of depression will be evaluated in individuals with and without SCI.

SCI subjects with high muscle tone (High frequency)

EXPERIMENTAL

Stage 3 subjects:A rehabilitation program of machine driven passive stretch(High frequency) will be executed .

Device: home-based ankle continuous passive motion machine.

SCI subjects with high muscle tone(low frequency)

EXPERIMENTAL

Stage 3 subjects:A rehabilitation program of machine driven passive stretch(Low frequency) will be executed.

Device: home-based ankle continuous passive motion machine.

SCI subjects with high muscle tone

NO INTERVENTION

Stage 3 subjects:Control subjects

Interventions

home-based ankle continuous passive motion machine.DEVICE

A rehabilitation program of machine driven passive stretch.

SCI subjects with high muscle tone (High frequency)SCI subjects with high muscle tone(low frequency)

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of spinal cord injury \< 2 years
  • Stage 2 subjects: Incomplete spinal cord injury subject
  • Clinical diagnosis of incomplete spinal cord injury
  • ASIA classification:B, C, or D
  • Stage 3 subjects: Spinal cord injury subjects with high muscle tone
  • Clinical diagnosis of spinal cord injury.
  • ASIA classification: A, B, C, or D

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung University

Taoyuan District, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 16, 2013

First Posted

October 23, 2013

Study Start

August 1, 2013

Primary Completion

July 1, 2015

Last Updated

October 23, 2013

Record last verified: 2013-10

Locations

TW(1)